FDA WARNING_LETTER - Amish Origins Management, LLC - January 10, 2025

The FDA inspected Amish Origins Management, LLC, from January 7-10, 2025, uncovering significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. Several products were also cited as unapproved new drugs and misbranded. CGMP deficiencies included failure to perform adequate release testing for finished drug products (21 CFR 211.165), insufficient identity testing for components, particularly high-risk glycerin for DEG/EG, and failure to validate supplier COAs (21 CFR 211.84). The firm also lacked complete batch production and control records (21 CFR 211.188) and had an ineffective quality control unit (21 CFR 211.22). Additionally, AMISH ORIGINS AUTHENTIC DEEP PENETRATING Pain Relief Spray, Ointment, Cream, and Aloe are unapproved new drugs (FD&C Act sections 505(a), 301(d)) as their indications do not comply with OTC monograph M017. These pain relief products are also misbranded under section 502(ee). The AMISH ORIGINS AUTHENTIC LIP DOC SPF 15 MEDICATED is misbranded under section 502(f)(2) for inadequate warnings and also under 502(ee). The FDA recommends engaging a CGMP consultant. The firm must respond within 15 working days with a detailed plan for corrective actions and prevention. Non-compliance may result in regulatory actions such as seizure, injunction, and impact on export certificates or application approvals.